Genesis MedTech Secures FDA Breakthrough Device Designation for Innovative J-Valve™ Transfemoral System
Genesis MedTech, a renowned leader in the field of medical devices, has officially announced that the J-Valve™ Transfemoral (TF) System has been granted the prestigious Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). This revolutionary heart valve has earned this designation for its intended use in treating severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. The device is specifically intended for patients who are considered high-risk candidates for traditional open surgical aortic valve replacement, as determined by a heart team.
The innovative J-Valve™ TF System offers a minimally invasive transcatheter aortic valve replacement procedure, eliminating the need for invasive open-heart surgery or extracorporeal circulation. This is achieved through a sophisticated anchoring mechanism and an expandable stent frame, providing secure attachment to a compromised valve. By restoring normal blood flow from the heart to the body, the J-Valve™ TF system has the potential to alleviate symptoms associated with heart failure, such as shortness of breath, chest pain, and fatigue.
Comprising two essential components the J-Valve™ TF Bioprosthesis and the J-Valve™ TF Delivery Device—the system is meticulously designed. The bioprosthesis includes bovine pericardium leaflets, a nitinol stent frame enveloped in polyester fabric, and a nitinol anchor ring. The delivery device is instrumental in precisely positioning the bioprosthesis within the patient's native aortic valve.
The designation of Breakthrough Device for the J-Valve™ TF System is a testament to its remarkable potential in advancing cardiovascular care. This recognition is reserved for devices that exhibit the promise of significantly improving the treatment or diagnosis of specific medical conditions. In bestowing this honor, the FDA acknowledges the groundbreaking nature of the J-Valve™ TF System and its potential to revolutionize patient outcomes and medical practices.